DeRoyal Sterile Custom Sterile Custom Surgical Kits recall
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF…
Why was DeRoyal Sterile Custom Sterile Custom Surgical Kits recalled?
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF 89-5720.04, Lot Number 38322988; REF 89-6717.03, Lot Numbers: 38323059 and 38342436
- Product
- DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF…
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- N/A
- Distribution
- SC, FL, OH, NJ, OK, MN, AR
- Recall date
- November 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)